Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- Endoscopy preparation kit FDA UDI
- Model / Reference
- 00884450409442 FDA UDI
Identifiers
- Catalog Number
- K20T-00031 FDA UDI
- Primary DI / UDI-DI
- 00884450409442 FDA UDI
- FDA Product Code
- NWU FDA UDI
- GMDN Term
- Endoscopy preparation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopy preparation kit
A comprehensive endoscopy preparation kit used in the preparation of a patient for gastrointestinal or airway procedures. The Merit Medical Endoscope Introducer Kit is designed to support the procedure with various tools and equipment.
Similar devices
Also classified as Endoscopy preparation kit.
- Endo Carry-On Procedure Kit — MEDIVATORS INC. · Class II
- Custom Procedure Kit — MEDIVATORS INC. · Class II
- Compliance EndoKit™ — Boston Scientific · Class I
- Endo-Carry-on Procedure Kit — MEDIVATORS INC. · Class II
- Custom Procedure Kit — MEDIVATORS INC. · Class II
- Compliance EndoKit™ — Boston Scientific · Class I
- Endo Carry-on Procedure Kit — MEDIVATORS INC. · Class II
- VIA — US Endoscopy · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 23334ff6-ab4c-477d-aee0-2779dafb6c95 33 fields · synced Jul 20, 2026